QT Imaging has received the US Food and Drug Administration (FDA) 510(k) clearance for an updated configuration of its Breast Acoustic CT scanner, a 3D ultrasound tomographic breast imaging system.
The enhanced configuration aims to increase visualisation and extend coverage of posterior breast tissue.
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The CT scanner reconstructs 3D tomographic images by utilising both reflection-mode and transmission-mode ultrasound data.
Its software quantifies fibroglandular tissue volume and ratio to total breast volume, offering valuable insight for assessment and monitoring in breast health.
QT Imaging chief science officer Bilal Malik said: “The updated configuration cleared by the FDA incorporates a tilted transmitter geometry that improves tomographic imaging coverage of breast tissue located near the chest wall, which is an area that can be extremely challenging to capture.
“This design delivers more complete coverage and improved overall diagnostic utility by optimising the scanner’s ability to include posterior breast tissue that is often difficult to image with standard approaches.
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By GlobalData“We remain dedicated to developing and refining innovative technologies that provide greater precision and confidence to deliver the best outcomes for women regardless of breast density.”
QT Imaging is involved in research, development, and commercialisation of imaging systems utilising low frequency sound waves. The company’s approach centres on improving global health outcomes through medical imaging that is accessible, affordable, safe, and focused on patient experience.
In January 2026, the company announced a new partnership with Olea Medical to advance cloud-based breast imaging analytics.
The partnership aims to integrate Olea Medical’s advanced visualisation, quantitative analytics, and AI-ready imaging technologies into QT Imaging’s Cloud SaaS Platform, supporting research workflows, quantitative imaging analysis, and clinical interpretation.
